Nitrofurantoin Capsules USP — Class III drug recall D-0273-2019

Terminated recall by AMERICAN HEALTH PACKAGING, reported 2018-11-28, distributed nationwide. Cross contamination with other products: This sub-recall is being initiated in support of the recall by the ma

Recall number	`D-0273-2019`
Product type	Drug
Classification	Class III
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	AMERICAN HEALTH PACKAGING, Columbus, OH, United States
Recall initiated	2018-11-09
Classified	2018-11-20
Reported by FDA	2018-11-28
Terminated	2020-09-30
Distributed	Nationwide (US)
Quantity	4,508 blister
NDC	`68064-0446-11`, `68084-0446-01`
Lot numbers	`180310`, `180612`
Expiration dates	`2020-03-31`

Product

Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100-count Unit Dose Blisters, Rx only, Amerisource Health Services DBA American Health Packaging, 2550-A John Glenn Avenue Columbus, OH 43217, NDC 68084-446-01 (Individual Dose NDC: 68064-446-11)

Reason for recall

Cross contamination with other products: This sub-recall is being initiated in support of the recall by the manufacturer (Sandoz) dated 11/1/18, which included lots that were repackaged by American Health Packaging. Sandoz stated that "These lots are being recalled due to the potential presence of unrelated ingredients (i.e. traces of active ingredients of Benazepril, Haloperidol and Perphenazine), which were identified through a manufacturing investigation."

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0273-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.